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Theratechnologies Reports Phase 3 Results for TH9507 in HIV associated Lipodystrophy: 15% reduction in VAT
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December 19, 2006
Press Release from company.
Primary endpoint and important secondary endpoints achieved
TH9507 well tolerated by patients
Company to initiate second pivotal, confirmatory study
Montreal, December 19, 2006 - Theratechnologies (TSX:TH) today announced positive top line results for its Phase 3 clinical trial, testing the Company's lead compound, TH9507, in patients with HIV-associated lipodystrophy, a serious medical condition common in HIV patients. The study was powered to detect an 8% reduction in visceral adipose tissue (VAT) versus placebo. After 26 weeks, patients on TH9507 achieved a 15% reduction in VAT versus baseline and a 20% difference versus placebo. Further, TH9507 was shown to be well tolerated by patients.
Yves Rosconi, President and Chief Executive Officer of Theratechnologies, stated, "We are very excited by the results that we are announcing today. These data add strong support to our clinical development plans for TH9507. The emerging efficacy/safety profile of TH9507 is exactly what we were hoping for. It has great prospects as a treatment for excess visceral fat accumulation in HIV patients, with potential advantages over other approaches being developed. The next step is to confirm these results through a second study. The preparations for the new study in North America and Europe are well advanced and we expect to enroll our first patients during the first quarter of 2007", Mr. Rosconi added.
Efficacy
The primary endpoint was a reduction in VAT. Patients treated with TH9507 achieved an average reduction of 15% in VAT versus baseline after 26 weeks, compared to an average increase of 5% in the placebo group. The net result was a 20% difference versus placebo (p< 0.001). In absolute terms, the average VAT reduction was 28 square centimetres. Overall body fat was preferentially lost in the visceral cavity, with no clinically significant changes in subcutaneous adipose tissue (SAT) or limb fat. The 19% of patients who were glucose-intolerant responded equally well to the treatment.
Cholesterol profiles for the active group improved during the 26-week treatment period, denoted by a statistically significant decrease in the total cholesterol to HDL cholesterol ratio, also known as atherogenic index (p < 0.001 versus placebo). Triglyceride levels also decreased significantly versus the placebo group (p < 0.001).
Safety
TH9507 was generally well tolerated by study participants and the safety profile was in line with. what has been seen in Theratechnologies' previous studies. There were no clinically significant differences between the TH9507-treated group and placebo in glycemic control. No patients discontinued the study as a result of glycemic control problems
Theratechnologies anticipates releasing additional, more detailed data from this study through scientific meetings and journals in the coming months.
About the TH9507 Phase 3 program
HIV-associated lipodystrophy is closely associated with anti-retroviral therapy regimens. It is characterized by major physical changes (notably abdominal fat accumulation and/or loss of peripheral subcutaneous fat) as well as lipid and carbohydrate disorders (high cholesterol and blood sugar), conditions that can foster cardiovascular disease and type 2 diabetes. Patient discomfort with such abnormalities may also discourage compliance with HIV regimens.
TH9507, a stabilized analogue of the growth hormone releasing factor (GRF), is aimed at reducing excess abdominal fat or VAT in lipodystrophy patients. There is currently no approved treatment for this condition, which affects an estimated 250,000 HIV-infected patients in North America and Europe.
This first Phase 3 trial enrolled 412 patients in a multi-center, double-blind, randomized, placebo-controlled study conducted in 43 centers in the United States and Canada. The study is examining the safety and efficacy of a daily administration of 2 milligrams of TH9507 for a period of 26 weeks and long-term safety over 52 weeks. The primary endpoint is a reduction of visceral adipose tissue, or VAT, which is a risk factor for cardiovascular disease and type 2 diabetes.
A second Phase 3 trial to confirm the results of the first trial is required by regulatory authorities. The second trial is similar to the first trial in size and design and is set to get underway in North America and Europe during the first quarter of 2007. Theratechnologies received a Special Protocol Assessment (SPA) for the second trial from the U.S. Food and Drug Administration (FDA) in August 2006.
Conference call and Web cast
The Company will hold a conference call and web cast today at 8:00 a.m. to discuss the results.
To listen in, dial: 1-416 644-3424 or 1-800-731-6941 (toll free). Please call 5 minutes prior to the conference in order to ensure your participation. The webcast will be accessible at the following links: http://www.investorcalendar.com/ and http://www.theratech.com
A replay of the conference call will be available from 10:00 am today, December 19, 2006 until December 26, 2006 at 11:59 pm at the following number: 1-416-640-1917, pass code 21214033# or 1 877-289-8525, pass code 21214033#. The web cast will be posted for 90 days at the following links: http://www.investorcalendar.com/ and http://www.theratech.com
About Theratechnologies
Theratechnologies is a Canadian biopharmaceutical company that discovers or acquires novel therapeutic products for development and commercialization. These products target unmet medical needs in commercially attractive specialty markets. The most advanced program is TH9507 in Phase 3 clinical development in HIV-associated lipodystrophy. The Company also has other promising projects at various stages of development.
This press release contains forward-looking statements regarding the clinical development of TH9507 and its future commercialization. Such statements inherently involve numerous risks and uncertainties, including, without limitation, the successful and timely completion of clinical trials and the granting of the necessary authorizations. Actual future results may differ materially from the anticipated results. Investors are cautioned against placing undue importance on the forward-looking information contained in this press release and should consult pages 16 and 17 of the Company's 2005 Annual Report, which contains a more exhaustive analysis of risks and uncertainties connected to the business of the Company.
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